Drugs Controller General of India (DCGI) on Tuesday canceled the licenses of as many as 18 pharmaceutical companies. According to media reports, the decision was taken following an inspection and it was found that these companies were manufacturing spurious or substandard drugs.
According to the order issued on Tuesday, the drug regulator conducted an inspection of 76 companies in 20 states. However, the name of the companies is not yet known. The inspection was conducted jointly by central and state governments. Reportedly, the regulators have identified 203 firms. A majority of the companies are from Himachal Pradesh (70), followed by Uttarakhand (45) and Madhya Pradesh (23).
This inspection comes at a time after questions are being raised over the quality of Indian-manufactured drugs that are being sold abroad.
“Any violation of good manufacturing practices (GMP) is a public health hazard. It is important to ensure patients can access breakthrough innovations while upholding ethical codes and maintaining strict regulatory standards. This is crucial to maintain patient safety and trust. At OPPI our strategy is to focus on ‘Bharat Ke Liye’, and our member companies have always endeavored to meet Indian patients’ needs. In line with this, we ensure following the highest levels of global ethical codes, and business practices, as well as the OPPI code of conduct that is based on the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) and IFPMA code of conduct. The ethical quotient of our member companies is extremely high and at par with global standards,” Vivek Sehgal, Director General, OPPI told Financial Express.com.
Earlier this year, the WHO again issued an alert against two cough syrups manufactured by Noida-based Marion Biotech after the syrups were linked to the death of 18 children in Uzbekistan.
In February this year, the United States health authorities warned against the use of eye drops sold by Chennai-based Global Pharma Healthcare after the product led to one person’s death and multiple cases of vision loss.
In October last year, the WHO had issued a warning alert against four cough and cold syrups, manufactured by Haryana-based Maiden Pharmaceuticals, after 66 children allegedly lost their lives in The Gambia.
“Moreover, to counter the issue of counterfeit drugs, while making basic information about the drug available to patients, the Drugs Technical Advisory Board (DTAB) has recommended introducing QR codes in drug products to help authenticate and track and trace these drugs across the supply chain. Such technology-aided solutions and forward looking steps will help address the drug quality challenge. Consider the adoption of blockchain-based pharma solutions to ensure higher quality control across the value chain – vendors, distributors, bottling and packaging, and retailing,” Seghal told Financial Express.com.
He also said that as a research based industry association, they will remain committed to patient safety and building patient awareness.
“We will continue to collaborate with the government to discuss pathways for cohesive approaches to building robust and resilient regulatory systems across the nation,” he added.